Exercise Adherence and Cognitive Decline: Phase 2

NCT07127965 | Recruiting DMC

• 1 other identifier: 25-0479
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to conduct a test of a goals-based program to help people exercise more. This program was designed for individuals aged 45-65 from the Black community. Low levels of physical activity are related to health problems such as heart disease, diabetes, and cognitive decline. People of color are more negatively impacted by these conditions and have also historically been underrepresented by research seeking to increase physical activity. The investigators have developed this goals-based exercise promotion program with the help of a Black-led community-based organization (The Gyedi Project) and a Community Advisory Board made up of stakeholders in the Black community.

Conditions

Cognitive Decline

Keywords

Goals; Goal Difficulty; Exercise Intensity; Cognitive Decline

Outcome Measures

Primary Outcomes (27)

• Blood Pressure

  Blood pressure (systolic and diastolic) of all participants is collected before the intervention

  Baseline, Visit 15 (6 Months after baseline), Visit 17 (12 months after baseline)

• Activity Levels

  Exercise Intensity (PAR). Answers are direct (ex. how many hours active) and not scaled. Information is requested for the week and the past 3 months.

  Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)

• Sleep Levels

  Exercise Intensity (PAR). Answers are direct (ex. how many hours did you sleep) and are not scaled. Information is requested for the past 7 days.

  Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after followup)

• Exercise Intensity

  Exercise Intensity (PAR). Answers are direct (ex. how many hours did you sleep) and are not scaled. Information is requested for the past 7 days.

  Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)

• Exercise Behavior

  L-Cat. Single question that asks about frequency/rigor of physical activity, with six potential answers ranging from no physical activity to daily physical activity.

  Baseline, Visit 17 (12 months after Baseline)

• Exercise Behavior

  modified Godin Shepard Leisure Time Physical Activity Questionnaire. Measures physical and leisure activity over a typical one week period

  All study timepoints (Visits 1-17; approximately 14 months)

• Theoretical Mediators of Exercise Behavior

  Intrinsic Motivation Inventory. Questions relate to how participants think or feel about physical activity, with answers ranging from 1 (strongly disagree) to 7 (strongly agree). Broader scores are broken up into subscales; final subscale scores are summed and averaged. Higher scores indicate higher agreement with that subscale.

  Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)

• Theoretical Mediators of Exercise Behavior

  Self-Efficacy. 9 questions about confidence in exercise on scale of 1 (disagree strongly) to 7 (agree strongly). Higher scores indicate higher perceived confidence in doing that activity. Total scores are summed.

  Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)

• Theoretical Mediators of Exercise Behavior

  Exercise Intention Survey. Scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree) to indicate level of agreement to statements related to intention to exercise. Scores are summed to produce a total score. Higher scores indicate stronger intention to exercise, lower scores indicate weaker intention.

  Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)

• Theoretical Mediators of Exercise Behavior

  Exercise Identity Score. Scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree) to indicate level of agreement to statements related to attitudes towards exercise. Scores are summed and averaged to provide an overall score. Higher scores indicate a positive attitude towards exercise, lower scores less favorable attitude.

  Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)

• Theoretical Mediators of Exercise Behavior

  Exercise alignment with Black identity. Assessment of the extent to which 7 common exercises are aligned with Black identity

  Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)

• Heart Rate Variability

  Heart Rate Variability is measured using chest strap monitor.

  Baseline, Visit 17 (12 months after Baseline)

• Heart Rate

  Heart Rate is measured using chest strap monitor.

  Baseline, Visits 2-13 (Supervised Exercise Training, 1 hour 3x/week for 4 weeks), Visit 15 (6-month follow-up), Visit 17 (12-month follow-up)

• Ventilatory Threshold

  Talk Test. Graded treadmill test where intensity is increased at intervals to determine participant's ventilatory threshold.

  Baseline

• Perceived Exertion

  A single-item measure from Borg (1973) was used to assess participants' rate of perceived exertion (RPE) during the exercise bout. Participants were asked to rate the average intensity of exercise \[at that moment/during the past ten minutes\] on a 25-point scale ranging from 6 (no exertion at all) to 20 (maximal exertion).

  Baseline, Visits 2-13 (Supervised Exercise Training, 1 hour 3x/week for 4 weeks)

• Pain Levels

  A single item measure from Borg (1998) was used to assess participants' pain levels during the exercise bout. Participants were asked to indicate how much pain they felt \[at that moment/during the past ten minutes\] on an 11-point scale ranging from 0 (nothing at all) to 10 (excruciating).

  Visits 2, 6, 12 (Supervised Exercise Training)

• Affective Valence

  The Feeling Scale, a single-item measure from Hardy and Rejeski (1989), was used to assess participants' affective valence during the exercise bout. Participants were asked to indicate how they felt \[at that moment/during the past ten minutes\] on an 11-point scale ranging from -5 (very bad) to +5 (very good).

  Visit 12, Visits 14-16 (3, 6, and 9 months after baseline)

• Affective Arousal

  The Felt Arousal Scale, a single-item measure from Svebak and Murgatroyd (1985), was used to assess participants' affective arousal during the exercise bout. Participants were asked to indicate how "worked-up" they felt \[at that moment/during the past ten minutes\] on a 6-point scale ranging from 1 (low arousal) to 6 (high arousal).

  Visits 2, 6, 12 (Supervised Exercise Training)

• Enjoyment

  A single item measure from Gillman and Bryan (2015) was used to assess participants' enjoyment levels during the exercise bout. Participants were asked to indicate how enjoyable exercise was \[at that moment/during the past ten minutes\] on a 5-point scale ranging from 1 (no enjoyment at all) to 5 (a great deal of enjoyment).

  Visits 2, 6, 12 (Supervised Exercise Training)

• Exercise Check-In

  Three short questions assessing if the participant planned to engage in exercise and how many minutes of moderate (0-120) and vigorous (0-60) exercise they engaged in

  Visits 14-17 (3, 6, 9, and 12 months after baseline)

• Exercise Benefits and Barriers

  A 10 item scale assessing perceived benefits of and barriers to exercise

  Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)

• Anthropometrics

  Height will be measured in centimeters

  Baseline, Visit 17 (12-month follow-up)

• Diet

  NCI's Eating at America's Table Study (EATS) Fruit \& Vegetable All-Day Screener. A short dietary assessment instrument for measuring fruit and vegetable intake over the past month.

  Baseline, Visit 17 (12-month follow-up)

• Demographics

  Survey includes gender, sexual orientation, age, detailed race/ethnicity, and SES

  Baseline

• Objective Physical Activity

  Objective physical activity will be measured through ActiGraph. Participants will be given the ActiGraph at baseline and will be asked to wear the device for one week. Participants will then be asked to wear the watch continuously for the week before visit 15 (6-month follow-up) and visit 17 (12-month follow-up).

  Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)

• Biomarkers of Cognitive Aging

  Biomarkers of cognitive again will be analyzed by blood samples. Blood samples will be collected at baseline and Visit 17 (12-month follow-up) and stored. At the end of the study, samples will be sent for analysis of biomarkers involved in cognitive aging, including p-tau181, NfL, Ab40, Ab42, GFAP, and IGF-1.

  Baseline and Visit 17 (12 months after baseline)

• Anthropometrics

  Weight will be measured in pounds

  Baseline, Visit 17 (12-month follow-up)

Study Arms (4)

Moderate Intensity Exercise, Basic Goal Difficulty

EXPERIMENTAL

Participants are assigned to exercise at a moderate intensity and create basic goals

Behavioral: Goal Setting and Exercise Intensity Intervention

Moderate Intensity Exercise, Challenging Goal Difficulty

EXPERIMENTAL

Participants are assigned to exercise at a moderate intensity and create challenging goals

Behavioral: Goal Setting and Exercise Intensity Intervention

Vigorous Intensity Exercise, Basic Goal Difficulty

EXPERIMENTAL

Participants are assigned to exercise at a vigorous intensity and create basic goals

Behavioral: Goal Setting and Exercise Intensity Intervention

Vigorous Intensity Exercise, Challenging Goal Difficulty

EXPERIMENTAL

Participants are assigned to exercise at a vigorous intensity and create challenging goals.

Behavioral: Goal Setting and Exercise Intensity Intervention

Interventions

Goal Setting and Exercise Intensity Intervention BEHAVIORAL

Participants' goal-setting and exercise intensity are manipulated based on group assignment.

Moderate Intensity Exercise, Basic Goal Difficulty; Moderate Intensity Exercise, Challenging Goal Difficulty; Vigorous Intensity Exercise, Basic Goal Difficulty; Vigorous Intensity Exercise, Challenging Goal Difficulty

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<3 incorrect responses on the Pfeiffer Mental Status Questionnaire
• Ages 45 to 65
• Consent to be randomized to conditions
• Planning to remain in the Denver metro area for the next 14 months
• Identify as Black or African American

You may not qualify if:

• Currently physically active (i.e., \>90 min/week of moderate PA or \>40 min/week of vigorous PA consistently for the past 6 months)
• On antipsychotic medications or currently under treatment for any serious psychiatric disorder including Alzheimer's or dementia
• Inability to walk 3 blocks without chest pain, shortness of breath, or lightheadedness
• Inability to climb 2 flights of stairs without chest pain, shortness of breath, or lightheadedness
• Answers "yes" to 1 or more of the 7 general questions of the PAR-Q+ and answers yes to any of the follow up questions.
• Blood pressure at baseline is greater than 160/100
• Blood pressure at baseline is between 140/90 - 160/100 and the participant is currently taking blood pressure medication
• Blood pressure \> 210/90 mmHg (for men) or \> 190/90 mmHg (for women) immediately after exercise

Sponsors & Collaborators

• University of Colorado, Boulder: lead

Study Sites (2)

Recreation Centers in the Denver Metro Area

Aurora, Colorado, 80309, United States

RECRUITING

University of Colorado at Boulder

Boulder, Colorado, 80309, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Sarah Frances Crawford, B.A.

CONTACT

423-771-1244; Sarah.Crawford-1@colorado.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 17, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (2)